There are two basic methods currently used for blood collection and separation of blood into its component parts: a manual method and apheresis.
The current method of collecting and processing whole blood into its components (red cells, plasma, platelets) takes 75 to 90 minutes per unit. The process begins with the manual whole blood collection from a donor, which takes about 12 to 15 minutes. Then the unit of whole blood and test samples are transported to a fixed blood components laboratory where the whole blood is tested, centrifuged, expressed, labeled, leukoreduced, and placed into inventory. Further centrifugation and handling are required to produce platelets.
In the United States, collection of certain components are more frequently performed using apheresis. Apheresis is an automated process in which the donor blood is collected and stripped of a desired component. The remainder is then returned to the donor. For example, plateletpheresis is the automated removal of platelets from the body through the withdrawal of blood, its separation into red blood cells, plasma, and platelets, and the re-infusion of the red blood cells and plasma back into the body.
In general, manual methods of collection and separation of blood are less efficient than automated methods such as aphaeresis. For example, with the manual method of platelet collection six collections are required to produce a therapeutic dose.
Additionally, the regulatory climate and issues affecting the donor population would also appear to favor an alternative approaches to the current blood collection procedures including the standard manual collection and separation process.
Blood products are biological products, and blood centers must therefore operate under the United States Food and Drug Administration's (FDA) regulations and established practices. Operating in compliance with regulations and practices when utilizing manual collection and processing procedures imposes an enormous quality assurance burden, under which more than one-half of blood centers in the United States still fail to operate.
Moreover, new regulations are being proposed. For example, leukocytes have been identified to cause negative physiological reactions in a small percentage of blood transfusion recipients. As a result, the FDA's Blood Products Advisory Committee has formally recommended that the FDA mandate leukocyte reduction and nations around the world, including Canada and the United Kingdom, have adopted leukocyte filtering. Leukocytes are currently removed from red cells and platelets by manual filtration processes which are time consuming and labor intensive.
The donor population in the United States and elsewhere is expected to decline by approximately 8% from its level in 2002. The decline is anticipated for a variety of reasons, including more stringent donor screening to prevent contamination of the blood supply by various diseases. Some entities have proposed the collection of two red cell units during one donor session as a partial solution to supply problems. One study has suggested that the adoption of double red cell collection could reduce the required donor pool by 6% and continue to meet existing blood supply requirements from a smaller donor pool. However, many blood banks currently do not have the capacity to perform double red cell collection.
Although, clearly, manual processes for blood collection and separation have some serious disadvantages, they are generally far less expensive than the automated alternatives, such as aphaeresis, as they do not require specialized staff, expensive equipment and disposables. Additionally, the cumbersome apheresis equipment does not lend itself to use at mobile collection sites, where the majority of blood donations are collected. In part for these reasons, although apheresis is used extensively for certain procedures, such as platelet collection where up to sixty-five percent of platelets collected in the United States are collected using plateletpheresis, apheresis has not achieved high penetration or displaced the current manual processes for blood collection and separation. Similarly, double unit collection has not been implemented in part because current procedures for double unit collection are expensive and relatively complex. Finally, for some procedures, such as leukocyte filtering, there are few, if any, alternatives to a time consuming and expensive manual process.
It is therefore an object of this invention to provide an apparatus and system for blood collection that reduces direct collection and processing costs. It is a further object of this invention to automate and standardize collection and processing procedures, and to automate data collection to minimize errors. It is a further object of this invention to have an automated system of blood collection that has the capacity to perform multiple collection processes including the collection of both single and double units of red blood cells. It is a further object of this invention to provide a system that can perform all processes at remote sites on mobile blood drives as well as at fixed, blood center sites. And, it is an object of this invention to simultaneously collect, process, and leukofilter blood.